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Human medicine European public assessment report (EPAR): Piqray
Alpelisib, Breast Neoplasms
Date of authorisation: 27/07/2020,
, Authorised, Last updated: 30/07/2020
Piqray is a cancer medicine used to treat postmenopausal … women and men with breast cancer that is locally advanced … can only be used when the cancer cells have receptors for … -
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Human medicine European public assessment report (EPAR): Zercepac
trastuzumab, Breast Neoplasms, Stomach Neoplasms
Date of authorisation: 27/07/2020,, 
, Authorised, Last updated: 28/07/2020
Zercepac is a cancer medicine used to treat the … conditions: early breast cancer (when the cancer has spread within the breast … chemotherapy (medicines to treat cancer), and radiotherapy (treatment … -
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Human medicine European public assessment report (EPAR): Daurismo
Glasdegib maleate, Leukemia, Myeloid, Acute
Date of authorisation: 26/06/2020,, 
, Authorised, Last updated: 10/07/2020
glasdegib Overview Daurismo is a cancer medicine for treating adults … myeloid leukaemia (AML), a cancer of white blood cells. It … dose of cytarabine (another cancer medicine) when the patient … -
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Human medicine European public assessment report (EPAR): Reblozyl
Luspatercept, Anemia, Myelodysplastic Syndromes, beta-Thalassemia
Date of authorisation: 25/06/2020,, , Authorised, Last updated: 08/07/2020
myeloid leukaemia (a blood cancer) or of dying, and in whom … -
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Human medicine European public assessment report (EPAR): Sarclisa
Isatuximab, Multiple Myeloma
Date of authorisation: 30/05/2020,, Authorised, Last updated: 12/06/2020
isatuximab Overview Sarclisa is a cancer medicine used together with … treat multiple myeloma (a cancer of the bone marrow). It is … previous treatments for their cancer, including lenalidomide and … -
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Human medicine European public assessment report (EPAR): Zeposia
ozanimod hydrochloride, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 20/05/2020,, Authorised, Last updated: 27/05/2020
severe active infections, cancer or weakened immune system … severe active infections, cancer or weakened immune system … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide Mylan
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 01/04/2020,
, Authorised, Last updated: 17/04/2020
a rare form of leukaemia (cancer of the white blood cells … treatment with a retinoid and cancer medicines, or when their … -
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Human medicine European public assessment report (EPAR): Cinacalcet Accordpharma
cinacalcet hydrochloride, Hyperparathyroidism
Date of authorisation: 03/04/2020,, Authorised, Last updated: 15/04/2020
calcium levels) in adults with cancer of the parathyroid glands … also have parathyroid gland cancer or primary hyperparathyroidism … -
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Human medicine European public assessment report (EPAR): Ruxience
rituximab, Leukemia, Lymphocytic, Chronic, B-Cell, Arthritis, Rheumatoid, Microscopic Polyangiitis, Pemphigus
Date of authorisation: 01/04/2020,, , Authorised, Last updated: 07/04/2020
treat the following blood cancers and inflammatory conditions … non-Hodgkin’s lymphoma, a blood cancer); chronic lymphocytic leukaemia … leukaemia (CLL, another blood cancer affecting white blood cells … -
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Human medicine European public assessment report (EPAR): Azacitidine Mylan
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 27/03/2020,, Authorised, Last updated: 06/04/2020
myeloid leukaemia (AML, a cancer affecting white blood cells … myelomonocytic leukaemia (a cancer affecting white blood cells … experienced in the use of cancer medicines. Before receiving … -
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Human medicine European public assessment report (EPAR): Azacitidine betapharm
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 24/03/2020,, Authorised, Last updated: 01/04/2020
myeloid leukaemia (AML, a cancer affecting white blood cells … myelomonocytic leukaemia (a cancer affecting white blood cells … experienced in the use of cancer medicines. Before receiving … -
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Human medicine European public assessment report (EPAR): Nubeqa
darolutamide, Prostatic Neoplasms, Castration-Resistant
Date of authorisation: 27/03/2020,, Revision: 1, Authorised, Last updated: 28/05/2020
to treat men with prostate cancer. It is used when the cancer is castration-resistant (worsens … the treatment of prostate cancer. The recommended dose of Nubeqa … from stimulating prostate cancer cells from growing. What … -
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Human medicine European public assessment report (EPAR): Azacitidine Accord
azacitidine, Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute
Date of authorisation: 13/02/2020,, Authorised, Last updated: 21/02/2020
myeloid leukaemia (AML, a cancer affecting white blood cells … myelomonocytic leukaemia (a cancer affecting white blood cells … experienced in the use of cancer medicines. Patients should … -
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Human medicine European public assessment report (EPAR): Amsparity
adalimumab, Arthritis, Rheumatoid, Arthritis, Juvenile Rheumatoid, Psoriasis, Arthritis, Psoriatic, Spondylitis, Ankylosing, Uveitis, Colitis, Ulcerative, Crohn Disease, Hidradenitis Suppurativa
Date of authorisation: 13/02/2020,, , Authorised, Last updated: 14/02/2020
fight off infections and cancer, and there have been some … serious infections and blood cancers in patients using adalimumab … -
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Human medicine European public assessment report (EPAR): Polivy
polatuzumab vedotin, Lymphoma, B-Cell
Date of authorisation: 16/01/2020,, , 
, Authorised, Last updated: 27/01/2020
Polivy is a cancer medicine used to treat adults … B-cell lymphoma (DLBCL) whose cancer has returned or has stopped … diagnosis and treatment of cancer. Polivy is for infusion (drip … -
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Human medicine European public assessment report (EPAR): Mayzent
Siponimod fumaric acid, Multiple Sclerosis, Relapsing-Remitting
Date of authorisation: 13/01/2020,, Revision: 2, Authorised, Last updated: 04/05/2020
be used in patients with cancer and certain immune disorders … -
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Human medicine European public assessment report (EPAR): Vanflyta
quizartinib dihydrochloride, Leukemia, Myeloid, Acute
Date of refusal: 19/12/2019, Refused, Last updated: 06/01/2020myeloid leukaemia (AML) (a cancer of the white blood cells … Vanflyta was developed as a cancer medicine for the treatment … ‘FLT3-ITD positive’ (when the cancer cells have a certain change … -
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Human medicine European public assessment report (EPAR): Cegfila (previously Pegfilgrastim Mundipharma)
pegfilgrastim, Neutropenia
Date of authorisation: 19/12/2019,, , Revision: 3, Authorised, Last updated: 13/05/2020
Cegfila is a medicine used in cancer patients to help with neutropenia … is a common side effect of cancer chemotherapy and can leave … in patients with the blood cancer chronic myeloid leukaemia … -
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Human medicine European public assessment report (EPAR): Arsenic trioxide Accord
Arsenic trioxide, Leukemia, Promyelocytic, Acute
Date of authorisation: 14/11/2019,, Revision: 1, Authorised, Last updated: 08/07/2020
a rare form of leukaemia (cancer of the white blood cells … treatment with a retinoid and cancer medicines, or when their … -
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Human medicine European public assessment report (EPAR): Bortezomib Fresenius Kabi
bortezomib, Multiple Myeloma
Date of authorisation: 14/11/2019,, Revision: 1, Authorised, Last updated: 01/07/2020
multiple myeloma, a blood cancer, in the following groups of … cell lymphoma, another blood cancer, in untreated adults who cannot … experience in the use of cancer medicines. Bortezomib Fresenius … -
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Human medicine European public assessment report (EPAR): Ivozall
clofarabine, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Date of authorisation: 14/11/2019,, Authorised, Last updated: 16/03/2020
Ivozall is a cancer medicine that is used to … lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type … that are dividing, such as cancer cells). It belongs to the … -
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Human medicine European public assessment report (EPAR): Xospata
gilteritinib fumarate, Leukemia, Myeloid, Acute
Date of authorisation: 24/10/2019,, , Authorised, Last updated: 08/11/2019
Xospata is a cancer medicine used to treat adults … myeloid leukaemia (AML), a cancer of white blood cells. Xospata … only given to patients whose cancer cells have a particular change … -
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Human medicine European public assessment report (EPAR): Vitrakvi (updated)
larotrectinib sulfate, Abdominal Neoplasms
Date of authorisation: 19/09/2019,, , Revision: 1, Authorised, Last updated: 31/07/2020
Vitrakvi is a cancer medicine for treating solid … a day for as long as the cancer is stable and the side effects … doctor experienced in using cancer medicines and can only be … -
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Human medicine European public assessment report (EPAR): Posaconazole Accord
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Authorised, Last updated: 28/08/2019
for blood or bone marrow cancers or medicines used in haematopoietic … -
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Human medicine European public assessment report (EPAR): Posaconazole AHCL
posaconazole, Mycoses
Date of authorisation: 25/07/2019,, Authorised, Last updated: 28/08/2019
for blood or bone marrow cancers or medicines used in haematopoietic …